NEWS HIGHLIGHTS
Published Studies Related to Pentam (Pentamidine)
Pentamidine aerosol versus trimethoprim-sulfamethoxazole for Pneumocystis carinii
in acquired immune deficiency syndrome. [1995]
Pneumocystis carinii pneumonia remains one of the most common opportunistic
infections in patients with acquired immune deficiency syndrome (AIDS). Treatment
with either intravenous pentamidine or trimethoprim-sulfamethoxazole (TMP-SMX) is
frequently complicated by serious adverse reactions.follow-up there was no difference in
mortality.(ABSTRACT TRUNCATED AT 250 WORDS).
A randomized comparison of once-monthly or twice-monthly high-dose aerosolized
pentamidine prophylaxis. [1993]
aerosolized pentamidine prophylaxis... CONCLUSIONS: The data suggest, but do not prove, that a dose-response effect has
Aerosol pentamidine prophylaxis following Pneumocystis carinii pneumonia in AIDS
patients: results of a blinded dose-comparison study using an ultrasonic
nebulizer. [1991]
Pneumocystis carinii pneumonia (PCP) and the acquired immunodeficiency syndrome... CONCLUSIONS: These results demonstrate that biweekly administration of 60 mg or
Comparison of meglumine antimoniate and pentamidine for peruvian cutaneous
leishmaniasis. [2005]
Pentamidine was compared with meglumine antimoniate (Glucantime) for 80 patients
with cutaneous leishmaniasis due to Leishmania braziliensis in Peru. Of the 40
patients administered Glucantime (20 mg of antimony [Sb]/kg/day intravenously for
20 days), 31 cured (78%), 6 failed (15%), of which 5 were due to relapse, and 3
were lost to follow-up (7%)...
A randomized clinical trial of low dosage combination of pentamidine and
allopurinol in the treatment of antimony unresponsive cases of visceral
leishmaniasis. [2001]
visceral leishmaniasis (VL) patients... CONCLUSIONS: The study showed that the combination of pentamidine (half dose) and
Clinical Trials Related to Pentam (Pentamidine)
Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study [Active, not recruiting]
Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being
associated with human immunodeficiency virus (HIV). In absence of antiretroviral treatment
(ART), poor prognosis, high mortality and high relapse rates are characteristic of Ethiopian
VL patients with HIV co-infection. Conversely, co-infection can be successfully managed via
a combination of effective treatment of the initial episode, timely ART and prevention of
relapses.
Actually, until cellular immunity returns with ART, the patient is at risk of VL relapses,
which can result in death, severe illness, reduced ART efficacy, drug-resistance and
possibly transmission of drug-resistant Leishmania donovani. Patients most vulnerable to
relapses are those with high levels of immunosuppression, with previous VL episodes, or with
opportunistic infections (OIs). The most important factor to prevent relapses seems to be
the clearance of visible parasites.
Limited studies in Europe show that HIV co-infected patients may benefit from secondary
prevention with antimonials (part of mainstay treatment for VL in Ethiopia) and pentamidine
(PM), not used for VL treatment in Africa. Such maintenance treatment has not been studied
in African VL, but the poor outcomes without secondary prevention highlight a need of better
care to patients at risk of relapse.
This prospective cohort study aims at documenting the patient's outcomes of secondary
prophylaxis with PM in VL-HIV co-infection, in terms of time to relapse or death, safety and
feasibility, before it can be considered for general use in Ethiopia. A placebo group is
not included, due to the clear advantages of the intervention to the patient population.
A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma [Recruiting]
The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety
and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects
Undergoing Thermal Ablation
A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia [Completed]
To evaluate the delivery of a single dose of aerosolized pentamidine to children; to
evaluate the tolerance of pentamidine administration by mask; to compare intravenous
pentamidine first dose pharmacokinetics (blood levels) in children with information
previously collected on adults; and to compare plasma pentamidine levels in children after
an aerosolized treatment with levels previously collected on adults.
Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with
AIDS and is associated with a high death rate. Current approved treatment includes
intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which
are both effective in treatment of the first episode of PCP pneumonia. However, both
therapies have a 50 percent or greater incidence of adverse reactions. Because of serious
toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized
pentamidine (pentamidine given through inhalation) is as effective as intravenous
pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous
pentamidine. The study is the first step in evaluating the delivery of aerosolized
pentamidine to children.
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole [Completed]
Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of
intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and
who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and
tolerance of these regimens in this patient population.
Secondary: To obtain information on the rate of PCP breakthrough in infants and children
receiving parenteral pentamidine prophylaxis.
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected
children considered to be at high risk. In children younger than 5 years of age with
intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful
alternative.
Aerosols in the Treatment of Pneumocystis Pneumonia: A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy [Completed]
To compare the use of pentamidine aerosol (inhaled mist) with the standard intravenous
method of administration in patients with AIDS related Pneumocystis carinii pneumonia (PCP),
to measure the amount of pentamidine aerosol that actually reaches the lung, and to see if
close clinical observation is safer and as effective as drug therapy in the prevention of
PCP recurrences. To compare the efficiency of 2 nebulizers - the Respirgard II nebulizer and
the Cadema Aerotech II nebulizer. Aerosolized pentamidine was as effective as intravenous
pentamidine in treating PCP in animals. More of the pentamidine reached the lungs and less
was found in the liver and kidney after pentamidine was given by aerosol than after an
intravenous injection. This suggests that the toxicity of pentamidine may be less if given
by aerosol than if given by the intravenous route.
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